International Cyclotron, Inc., Hato Rey, Puerto Rico; Order Suspending Licensed Activities, 80982-80984 [2011-33088]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80982-80984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33088]


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NUCLEAR REGULATORY COMMISSION

[Docket Nos. 030-37882 & 030-37957; License Nos. 052-31352-01MD/52-
31352-02; EA-11-086; NRC-2011-0292]


International Cyclotron, Inc., Hato Rey, Puerto Rico; Order 
Suspending Licensed Activities

I

    International Cyclotron, Inc. (International Cyclotron; Licensee) 
is the holder of Byproduct Materials License Nos. 52-31352-01MD and 52-
31352-02, issued on August 20, 2009, by the U.S. Nuclear Regulatory 
Commission (NRC or the Commission) pursuant to Title 10 of the Code of 
Federal Regulations (CFR) part 30. License No. 52-31352-01MD authorizes 
the preparation and distribution of radioactive drugs and 
radiochemicals for medical and non-medical use and the possession and 
storage of byproduct materials incidental to radionuclide production. 
License No. 52-31352-02 authorizes the use of an accelerator to produce 
pharmaceutical radionuclides, the packaging and distribution of 
produced radiochemicals and sealed sources, possession and storage of 
byproduct materials incidental to radionuclide production, and 
calibration and checking of the licensee's instruments. The licenses 
are scheduled to expire on August 31, 2019.

II

    NRC regulations specified in 10 CFR 30.35 require that applicants 
for authorization to possess and use byproduct radioactive material 
above specified amounts must provide a guarantee or other financial 
arrangement that funds for decommissioning will be available when 
needed (i.e., financial assurance). The requirement to provide 
financial assurance is in addition to the licensee's regulatory 
obligation to decommission its facilities, and is to ensure that a 
suitable mechanism for financing the decommissioning of licensed 
facilities is in place in the event that a licensee is unable or 
unwilling to complete decommissioning.
    When International Cyclotron submitted its NRC license application 
related to the cyclotron, it requested authorization to possess and use 
radioactive material of half-life greater than 120 days and in 
quantities exceeding 10 \5\ times the applicable quantities set forth 
in appendix B to part 30. NRC regulations at 10 CFR 30.35(a)(1), 
require International Cyclotron to submit a Decommissioning Funding 
Plan (DFP) which, as described in 10 CFR 30.35(e), must consist of:
    1. A cost estimate for decommissioning;
    2. A description of the method for assuring funds for 
decommissioning;
    3. A description of the means for adjusting cost estimates and 
associated funding levels periodically over the life of the facility;
    4. A certification that financial assurance for decommissioning has 
been provided in the amount of the cost estimate; and,
    5. A signed original of the financial assurance instrument, which 
meets the regulatory requirements of 10 CFR 30.35(f).

International Cyclotron failed to submit the required DFP with its 
application. The NRC addressed this deficiency after issuing 
International Cyclotron the NRC license; in a letter dated December 7, 
2009, notified International Cyclotron of its requirement to provide 
financial assurance, advised International Cyclotron was in non-
compliance with 10 CFR 30.35, and requested that International 
Cyclotron come into compliance with NRC regulations and

[[Page 80983]]

submit the necessary supporting documentation.
    Between December 7, 2009, and October 12, 2011, the NRC contacted 
International Cyclotron on multiple occasions through letters, 
telephone calls, and electronic mail explaining the regulatory 
requirements for providing financial assurance. International Cyclotron 
has not provided NRC with information that demonstrates International 
Cyclotron has established financial assurance, as required by NRC 
regulations at 10 CFR 30.35.
    By letter dated September 2, 2011 (ML112450249), the NRC issued a 
Request for Additional Information (RAI) to International Cyclotron, 
which identified significant deficiencies in your draft decommissioning 
cost estimate and stated that ``you must re-submit your DFP and cost 
estimate in full, with all tables and any additional pages to provide 
sufficient description of the bases for your work and cost estimates.'' 
Additionally, the RAI advised International Cyclotron that the 
certification of financial assurance (CFA) is not accepted because: a) 
it is not an original, signed document by a management representative; 
and b) the CFA states that financial assurance in the amount of 
$1,125,000 has been obtained. Confirm that you will submit a revised 
CFA, and that it will be an original document with a signature from a 
management representative, in accordance with Appendix A.2.2, A.2.3, 
A.2.4 and A.2.5 of NUREG-1757, Vol.3; and that it will reflect the 
amount of decommissioning funding you are actually providing (at a 
minimum, the funding required will be the amount of the cost estimate 
as accepted by the NRC). The RAI letter required that International 
Cyclotron respond to the NRC within 30 days and stated that enforcement 
action would be initiated against International Cyclotron, if financial 
assurance requirements were not established.
    International Cyclotron failed to respond within 30 days. On 
October 14, 2011, International Cyclotron submitted a late response 
containing a signed cost estimate for decommissioning with a 
description of the method for assuring funds for decommissioning and 
the means for periodically adjusting the cost estimate (items 1, 2, and 
3 as noted above). The NRC reviewed those documents and found them to 
be acceptable. On October 24, 2011, International Cyclotron submitted 
another response containing a signed certification statement (item 4 
from above). The October 24, 2011 response, however, was incomplete and 
International Cyclotron remains in non-compliance because a financial 
assurance instrument fulfilling the requirements of 10 CFR 30.35(f) was 
not provided; International Cyclotron has not submitted the financial 
assurance instrument (item 5 from above) as of December 19, 2011.

III

    Based on the above factors, it appears that International Cyclotron 
has failed to meet the NRC requirements pertaining to financial 
assurance for decommissioning, contrary to 10 CFR 30.35. The NRC must 
be able to rely upon licensees to comply with NRC requirements. 
International Cyclotron's failure to obtain and submit a financial 
assurance instrument in the amount of the cost estimate has prevented 
the NRC from ensuring that funds will be available at the time of 
shutdown to provide for orderly and timely decommissioning to protect 
public health and the environment.

IV

    Accordingly, pursuant to sections 81, 161b, 161i, 161o, 182 and 186 
of the Atomic Energy Act of 1954, as amended, and the Commission's 
regulations in 10 CFR 2.202 and 10 CFR part 30, it is hereby ordered 
that:
    1. The authority to prepare and distribute radioactive drugs and 
radiochemicals under License No. 52-31352-01MD and to produce or handle 
radiochemicals and sealed sources, and package and distribute produced 
radiochemicals and sealed sources under License No. 52-31352-02 will be 
suspended, effective 60 days from the date of this Order, if the 
Licensee does not, within this 60-day period, provide a financial 
assurance instrument for decommissioning which the NRC determines is 
acceptable. The only activities that are not suspended are possession 
and storage of byproduct materials, and calibration and checking of the 
Licensee's instruments.
    2. From the date of suspension, until notified by the Commission in 
writing that a financial assurance instrument has been accepted; the 
Licensee shall restrict all activities except possession and storage of 
byproduct materials, and calibration and checking of the Licensee's 
instruments.
    3. The Licensee shall not receive any additional NRC-licensed 
material while the suspension is in effect.
    The Director, OE, may, in writing, relax or rescind any of the 
above conditions upon demonstration by the Licensee of good cause.

V

    In accordance with 10 CFR 2.202, the Licensee must, and any other 
person adversely affected by this Order may, submit an answer to this 
Order within 60 days of service of this Order. In addition, the 
Licensee and any other person adversely affected by this Order may 
request a hearing on this Order within 60 days of its publication in 
the Federal Register. Where good cause is shown, consideration will be 
given to extending the time to answer or request a hearing. A request 
for extension of time must be directed to the Director, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, and include a 
statement of good cause for the extension.
    All documents filed in NRC adjudicatory proceedings, including a 
request for hearing, a petition for leave to intervene, any motion or 
other document filed in the proceeding prior to the submission of a 
request for hearing or petition to intervene, and documents filed by 
interested governmental entities participating under 10 CFR 2.315(c), 
must be filed in accordance with the NRC E-Filing rule (72 FR 49139, 
August 28, 2007). The E-Filing process requires participants to submit 
and serve all adjudicatory documents over the internet, or in some 
cases to mail copies on electronic storage media. Participants may not 
submit paper copies of their filings, unless they seek an exemption in 
accordance with the procedures described below.
    To comply with the procedural requirements of E-Filing, at least 10 
days prior to the filing deadline, the participant should contact the 
Office of the Secretary by email at hearing.docket@nrc.gov, or by 
telephone at (301) 415-1677, to request (1) a digital ID certificate, 
which allows the participant (or its counsel or representative) to 
digitally sign documents and access the E-Submittal server for any 
proceeding in which it is participating; and (2) advise the Secretary 
that the participant will be submitting a request or petition for 
hearing (even in instances in which the participant, or its counsel or 
representative, already holds an NRC-issued digital ID certificate). 
Based upon this information, the Secretary will establish an electronic 
docket for the hearing in this proceeding if the Secretary has not 
already established an electronic docket.
    Information about applying for a digital ID certificate is 
available on NRC's public Web site at https://www.nrc.gov/site-help/e-
submittals/

[[Page 80984]]

apply-certificates.html. System requirements for accessing the E-
Submittal server are detailed in NRC's ``Guidance for Electronic 
Submission,'' which is available on the agency's public Web site at 
https://www.nrc.gov/site-help/e-submittals.html. Participants may 
attempt to use other software not listed on the Web site, but should 
note that the NRC's E-Filing system does not support unlisted software, 
and the NRC Meta System Help Desk will not be able to offer assistance 
in using unlisted software.
    If a participant is electronically submitting a document to the NRC 
in accordance with the E-Filing rule, the participant must file the 
document using the NRC's online, web-based submission form. In order to 
serve documents through EIE, users will be required to install a web 
browser plug-in from the NRC Web site. Further information on the web-
based submission form, including the installation of the Web browser 
plug-in, is available on the NRC's public Web site at https://www.nrc.gov/site-help/e-submittals.html.
    Once a participant has obtained a digital ID certificate and a 
docket has been created, the participant can then submit a request for 
hearing or petition for leave to intervene. Submissions should be in 
Portable Document Format (PDF) in accordance with NRC guidance 
available on the NRC public Web site at https://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the 
documents are submitted through the NRC's E-Filing system. To be 
timely, an electronic filing must be submitted to the E-Filing system 
no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of 
a transmission, the E-Filing system time-stamps the document and sends 
the submitter an email notice confirming receipt of the document. The 
E-Filing system also distributes an email notice that provides access 
to the document to the NRC Office of the General Counsel and any others 
who have advised the Office of the Secretary that they wish to 
participate in the proceeding, so that the filer need not serve the 
documents on those participants separately. Therefore, applicants and 
other participants (or their counsel or representative) must apply for 
and receive a digital ID certificate before a hearing request/petition 
to intervene is filed so that they can obtain access to the document 
via the E-Filing system.
    A person filing electronically using the agency's adjudicatory E-
Filing system may seek assistance by contacting the NRC Meta System 
Help Desk through the ``Contact Us'' link located on the NRC web site 
at https://www.nrc.gov/site-help/e-submittals.html, by email at 
MSHD.Resource@nrc.gov, or by a toll-free call at (866) 672-7640. The 
NRC Meta System Help Desk is available between 8 a.m. and 8 p.m., 
Eastern Time, Monday through Friday, excluding government holidays.
    Participants who believe that they have a good cause for not 
submitting documents electronically must file an exemption request, in 
accordance with 10 CFR 2.302(g), with their initial paper filing 
requesting authorization to continue to submit documents in paper 
format. Such filings must be submitted by: (1) First class mail 
addressed to the Office of the Secretary of the Commission, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: 
Rulemaking and Adjudications Staff; or (2) courier, express mail, or 
expedited delivery service to the Office of the Secretary, Sixteenth 
Floor, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland, 20852, Attention: Rulemaking and Adjudications Staff. 
Participants filing a document in this manner are responsible for 
serving the document on all other participants. Filing is considered 
complete by first-class mail as of the time of deposit in the mail, or 
by courier, express mail, or expedited delivery service upon depositing 
the document with the provider of the service. A presiding officer, 
having granted an exemption request from using E-Filing, may require a 
participant or party to use E-Filing if the presiding officer 
subsequently determines that the reason for granting the exemption from 
use of E-Filing no longer exists.
    Documents submitted in adjudicatory proceedings will appear in 
NRC's electronic hearing docket, which is available to the public at 
https://ehd.nrc.gov/EHD_Proceeding/home.asp, unless excluded pursuant 
to an order of the Commission, or the presiding officer. Participants 
are requested not to include personal privacy information, such as 
social security numbers, home addresses, or home phone numbers in their 
filings, unless an NRC regulation or other law requires submission of 
such information. With respect to copyrighted works, except for limited 
excerpts that serve the purpose of the adjudicatory filings and would 
constitute a Fair Use application, participants are requested not to 
include copyrighted materials in their submission.
    If a person other than the Licensee requests a hearing, that person 
shall set forth with particularity the manner in which his interest is 
adversely affected by this Order and shall address the criteria set 
forth in 10 CFR 2.309(d).
    If a hearing is requested by a licensee or a person whose interest 
is adversely affected, the Commission will issue an Order designating 
the time and place of any hearings. If a hearing is held, the issue to 
be considered at such hearing shall be whether this Order should be 
sustained. An answer or a request for hearing shall not stay the 
effectiveness of this order.

    Dated this 19th day of December 2011.

    For the Nuclear Regulatory Commission.
Roy P. Zimmerman,
Director, Office of Enforcement.
[FR Doc. 2011-33088 Filed 12-23-11; 8:45 am]
BILLING CODE 7590-01-P